Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Review
. 2024 Sep 16:61:17-23.
doi: 10.1016/j.jor.2024.09.015. eCollection 2025 Mar.

Comparison of hypoallergenic knee arthroplasties in patients with metal hypersensitivity versus standard arthroplasties in non-hypersensitivity patients: A scoping review

Christian Carulli  1 , Filippo Leggieri  1 , Domenico Rodà  1 , Fabrizio Matassi  1 , Roberto Civinini  1 , Matteo Innocenti  1
Affiliations
Review

Comparison of hypoallergenic knee arthroplasties in patients with metal hypersensitivity versus standard arthroplasties in non-hypersensitivity patients: A scoping review

Christian Carulli et al. J Orthop. .

Abstract

Background: Metal hypersensitivity in Total Knee Arthroplasty (TKA) continues to intrigue surgeons and researchers, with significant limitation of allergy tests due to the absence of clear cut-offs for a definitive diagnosis and their limited diffusion worldwide. We analyzed the literature to compare clinical outcomes in patients with metal hypersensitivity undergoing hypoallergenic knee arthroplasties and subjects without metal allergy undergoing standard knee arthroplasties.

Methods: This review adhered to PRISMA guidelines. A comprehensive search of MEDLINE, EMBASE, and Cochrane databases was conducted from inception to October 1st, 2023. Eligibility criteria included studies comparing clinical outcomes of hypoallergenic and standard knee arthroplasties in patients with and without metal hypersensitivity, respectively. Two independent reviewers screened studies, extracted data, and assessed risk of bias using the ROBINS-I tool. The primary outcome measure was the Knee Society Score (KSS). A random-effects model meta-analysis was performed to account for heterogeneity, with results expressed as standardized mean differences (SMD) with 95 % confidence intervals.

Results: From an initial 1846 studies identified, six met the inclusion criteria after rigorous screening. The quantitative included 409 knee replacements from three studies, comprising 95 hypersensitive patients who received hypoallergenic TKA and 314 non-allergic patients who underwent standard CoCr implant procedures. Risk of bias assessment revealedmoderate risk or lower across all included studies. Analysis of the KSS yielded an overall effect size (SMD) of -0.18 (95 % CI: -0.54 to 0.18), slightly favoring standard knee arthroplasties. Moderate heterogeneity was observed (I2 = 53 %, τ = 0.0526). The qualitative analysis included three studies. Significantly lower improvements were found in KSS, WOMAC, SF-12, and Euro-QoL-5D L-VAS among metal-sensitive patients. The third one reported no significant clinical differences between groups.

Conclusion: The scoping analysis showed similar clinical outcome after hypoallergenic TKA in patients with metal hypersensitivity compared to standard knee implants in patients without metal allergy.

Keywords: Hypersensitivity; Metal allergy; Nickel allergy; Patch test; Total knee arthroplasty.

PubMed Disclaimer

Conflict of interest statement

The authors did not receive support from any organization for the submitted work. The authors certify that they have NO affiliations with or involvement in any organization or entity with any financial interest, or non-financial interest in the subject matter or materials discussed in this manuscript.The authors declare the have no conflict of interest.

Figures

Fig. 1
Fig. 1
Research flowchart of the screening process for the studies included in the qualitative analysis and in the quantitative analysis according to PRISMA.
Fig. 2
Fig. 2
Risk-of-bias assessment with ROBINS-I tool shown as traffic lights chart.
Fig. 3
Fig. 3
Risk-of-bias assessment with ROBINS-I tool shown summary plot.
Fig. 4
Fig. 4
Forest plot of the KSS knee score.
See this image and copyright information in PMC

References

    1. Röhner E., Heinecke M., Matziolis G. Diagnostic algorithm in aseptic TKA failure - what is evidence-based? J Orthop. 2021;24:248–253. doi: 10.1016/j.jor.2021.03.006. Röhner E., e.roehner@waldkliniken-eisenberg.de; Heinecke M.; Matziolis G.) Orthopaedic Department of the Waldkliniken Eisenberg, University Hospital Jena, Eisenberg, Germany. - DOI - PMC - PubMed
    1. Mitchelson A.J., Wilson C.J., Mihalko W.M., et al. Biomaterial hypersensitivity: is it real? Supportive evidence and approach considerations for metal allergic patients following total knee arthroplasty. BioMed Res Int. 2015;2015 doi: 10.1155/2015/137287. - DOI - PMC - PubMed
    1. Middleton S., Toms A. Allergy in total knee arthroplasty: a review of the facts. Bone Jt J. 2016;98-B(4):437–441. doi: 10.1302/0301-620X.98B4.36767. - DOI - PubMed
    1. Guenther D., Thomas P., Kendoff D., Omar M., Gehrke T., Haasper C. Allergic reactions in arthroplasty: myth or serious problem? Int Orthop. 2016;40(2):239–244. doi: 10.1007/s00264-015-3001-6. - DOI - PubMed
    1. Ajwani S.H., Charalambous C.P. Availability of total knee arthroplasty implants for metal hypersensitivity patients. Knee Surg Relat Res. 2016;28(4):312–318. doi: 10.5792/ksrr.16.018. - DOI - PMC - PubMed

LinkOut - more resources